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Single Arm Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical Reperfusion System

NCT05429658 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2024-03-28

No results posted yet for this study

Summary

The objective of the study is to evaluate the safety and effectiveness of the Route 92 Medical Monopoint Reperfusion System with the Hi Point 88 and HiPoint 70 Reperfusion Catheters when used to aspirate emboli in acute ischemic stroke patients.

Conditions

  • Acute Ischemic Stroke

Interventions

DEVICE

Thrombectomy

The Route 92 Medical Reperfusion System is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease within the internal carotid, middle cerebral, basilar and vertebral arteries.

Sponsors & Collaborators

  • Route 92 Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Stefan Brew, MBChB, MHB · Auckland City Hospital

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-27
Primary Completion
2021-11-22
Completion
2022-02-24
FDA Device
Yes

Countries

  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05429658 on ClinicalTrials.gov